Genome Valley, Hyderabad - January 8th 2008: India’s most pioneering biotechnology company, Bharat Biotech International Limited (BBIL) announces the visit of the Honorable Secretary of the United States Department of Health and Human Services to its facilities at Genome Valley in Hyderabad.
Honorable Secretary Michael O. Leavitt, was sworn into office during January 2005, as the secretary of the US department of Health and Human Services, one of the largest civilian departments in the U.S. Federal Governments, with ~67,000 employees and 25% of the U.S. federal budget. Secretary Leavitt was instrumental in spearheading the US’s health diplomacy initiative aimed at improving the health of Central Americans and bringing the countries of North and Central America closer together. Prior to his current service, Leavitt was head of the U.S. Environmental Protection Agency and served three terms as Governor of Utah, which has been recognized as one of the best managed states in the United States. Governor Leavitt was also elected as the chairman as the United states Governors association.
Bharat Biotech International Ltd.:
Bharat Biotech International Limited, Hyderabad, India, is a multidimensional biotechnology company specializing in product-oriented research, development and manufacturing of vaccines and biotherapeutics. Bharat Biotech was established in the year 1996, is engaged in developing next-generation vaccines and biotherapeutics through innovative and collaborative research. Bharat Biotech sprawls over a picturesque campus at Genome Valley, Hyderabad, built with an investment of over USD 100 million, the facility’s Manufacturing, Control Procedures and Protocols, conform to the stringent standards laid down by internationally recognized institutions such as USFDA, UKMCA and WHO. Bharat has set new benchmarks in Innovation and Quality that epitomizes the tremendous progress of Indian biotechnology in the global arena.
BBIL has been in the forefront in developing and deploying novel health care solutions specifically designed for the populations of the developing world. These populations and the infectious diseases that affect them have long been ignored by multinational pharmaceutical companies. BBIL has developed few vaccines and therapeutics using the Public-Private-Private Partnership model with organizations within India and the United States.
Revac-B: a recombinant Hepatitis-B vaccine was the first product launched and sold more than 200 million doses both in India, Latin America, Asia and African continents. Two Global Patents were obtained on novel down stream processing (HIMAX) for this vaccine. Recently, for the first time in the world, launched Preservative (Thimersol) free vaccine in the market that speaks of our quality of the manufacturing process.
TYPBAR, a Vi capsular polysaccharide vaccine against typhoid fever, was developed in collaboration with Dr. John Robbins at the National Institutes of Health USA. Dr. John Robbins who has visited our facilities was instrumental in providing technological support and guidance for this project. BBIL is currently one of the largest manufacturers of polysaccharide typhoid vaccines world wide and is also in the process of developing next generation typhoid vaccines suitable for administration in infants.
INDIRAB, a chromatographically purified vero cell based anti rabies vaccine, was developed in collaboration with Dr. Charles Rupprecht at the Centers for Disease Control at Atlanta. Dr. Rupprecht’s vision of developing an anti rabies vaccine for the developing world to meet the demand for this life saving vaccine was implemented by the scientific and technical teams at BBIL. BBIL will be one of the largest producer of cell culture based anti rabies vaccine and supplying this vaccine to India and countries world wide.
PUBLIC-PRIVATE PARTNERSHIP:
Rotavirus: BBIL is currently involved in a large public-private partnership to develop 116E, an oral rotavirus vaccine, which was isolated at AIIMS in New Delhi and developed further at the Centers for Disease Control and the National Institutes of Health in the United States. This vaccine partnership is continuing for the last seven years under the guiding leadership of Dr. Roger I. Glass, Director of Fogarty International Center at NIH, and Dr. M.K. Bhan, Secretary of Dept. of Biotechnology. This partnership also involves the Bill and Melinda Gates foundation, PATH and the Indo US Vaccine Action Programme, making it truly a multi national Public-Private partnership between India and the United States. Both CDC (Dr. Roger Glass) and NIH (Dr. George Curlin) has been instrumental in guiding the development of 116E rotavirus vaccine on numerous technical and product development issues which is in Phase II trial.
Malarial Vaccine Candidates: A malarial vaccine candidate, FALVAC -1A, is being developed by Bharat Biotech Intl. Ltd. in collaboration with Centers for Disease Control (CDC), Atlanta, USA. This is a multi-epitope antigen against the deadliest malarial species Plasmodium falciparum. The molecule is in advanced stages of development and will soon go into the pre-clinical studies. BBIL technical team is also developing and testing several malaria vaccine candidates for protection against P. falciparum and P. Vivax. These candidates are being developed in partnerships with ICGEB, CDC, PATH and Bill and Melinda Gates Foundation. BBIL is confident that its efforts would result in developing a novel vaccine to protection against malarial fever and related health condition.
Private-Private Partnership with USA:
Wyeth – USA: BBIL set a precedent in the emerging area of Contract Manufacturing with the manufacture of HibTITER (Haemophilus Influenzae b Conjugate Vaccine) for Wyeth Limited. This was the first time that a vaccine was moved out of USA for manufacturing in India. BBIL has successful track record of manufacturing more than 2 Million Preservative Free vaccine for overseas regulated markets, by successfully completing Korean FDA. BBIL plant is the first injectable pharma plant approved by KFDA in India.
Agennix- USA: BBIL having state-of-the-art manufacturing plant and with wide range of manufacturing capabilities has manufactured Cancer therapeutic for clinical trials in India and USA.
Acambis- USA: BBIL is also manufacturing partner with ACAMBIS-USA for JE Vaccine development which is under final phase of clinical trial in India.
BIOPHARMACEUICAL DEVELOPEMNT:
REGEN-D: Bharat Biotech has commercialized India’s first recombinant Epidermal Growth Factor, REGEN-D™ to combat diabetic foot ulcers, burns. BBIL obtained PCT recently and published their clinical trials in the international reputed journals.
Novel Therapeutic Molecule: r-lysostaphin, a therapeutic protein against staph aureus infections for topical and intravenous use. This protein was developed, characterized by BBIL, with patents granted in the United States and several other countries. BBIL has completed phase I clinical trial for evaluating this protein in India and is in the process of evaluating this protein in other countries. This will be the first biotech IND molecule from India.
Important information about forward-looking statements
Certain statements in this press release may be considered “forward-looking”. Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the prospectus.
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